BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 8441084 · Received March 21, 2019

    Report

    Report Number
    1717344-2019-00386
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    September 21, 2018
    Report Date
    March 21, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). TITLE A COMPARISON OF SHORT-TERM OUTCOMES OF NECK DISSECTION FOR HEAD AND NECK CANCERS USING THUNDERBEAT¿, LIGASURE¿ OR TREATMENT WITHOUT AN ENERGY-BASED DEVICE: A CASE CONTROLLED STUDY SOURCE INTERNATIONAL JOURNAL OF SURGERY, VOLUME 58, 2018 (60-64), DATE OF PUBLICATION: 18 SEPTEMBER 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, WHILE PERFORMING NECK DISSECTION FOR HEAD AND NECK CANCER IT WAS THAT THE DEVICE GROUP HAD 6 REPORTED COMPLICATIONS. TWO PATIENTS HAD SURGICAL SITE INFECTIONS AND THREE LYMPHORRHEA WITH ONE OF THE CASES WAS BILATERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234173 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other